Occupational BalanceATENEUNCT05929430
Mindfulness in University Students. ATENEU Program
A study testing Mindfulness program and Mindfulness program with Virtual Reality in people with Occupational Balance and Mental Health Wellness, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
Trial summary
The study aims to examine the effects of a mindfulness-based intervention and a mindfulness-based intervention with virtual reality on occupational balance and on the reduction of psychological distress in university students (i.e. stress, anxiety and depression). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Occupational Balance, Mental Health Wellness, University Students
- What is being tested?
- Mindfulness program and Mindfulness program with Virtual Reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteSpain
- Study dates
- 2 Nov 2023to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being 18 years old or older
- being a degree, master or doctorate student at Miguel Hernández University
- speaking fluent Spanish
- signing the informed consent form
- having attended at least 4 of the 6 sessions (66% of the program)
- internet access from a computer or smartphone to complete the online assessments and formal practices during the program.
Who cannot join
- miss more than 2 out of 6 sessions (33% of the program)
- present a severe mental disorder in active phase diagnosed by a health professional (e.g., schizophrenia, bipolar disorder)
- are under the influence of alcohol or other drugs during sessions and/or assessments (determined by the program instructor)
- participate in another standardized meditation program during the study period
- withdrew before starting the intervention.
- Additionally, should any participants require psychological or psychiatric treatment during the study, they will be excluded and referred to specialized care services.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Alicia Sánchez Pérez
Sant Joan d'Alacant, Alicante, 03550
Alicia Sánchez Pérez, PhD, +34 96.591.9579, alicia.sanchez@umh.es
About this study
Official title: Effects of a Mindfulness Program on the Occupational Balance and Mental Health of University Students. Protocol for a Randomized Controlled Trial Study. ATENEU Program (Mindfulness in University Students)
The study aims to examine the effects of a mindfulness-based intervention and a mindfulness-based intervention with virtual reality on occupational balance and on the reduction of psychological distress in university students (i.e. stress, anxiety and depression). The specific objectives will be to examine the effects of the intervention on other variables related to mental health, psychological functioning and occupations, and their maintenance at three months.
Read the detailed description
The college student population is considered at high risk for developing mental health problems with the prevalence of depression being 34%, anxiety 32%, and sleep disorders 33% post-pandemic. This psychological distress affects students worldwide and is linked to poor academic performance and the presence of health risk behaviors such as substance use or suicide. Addressing student mental health is an urgent research priority. As such, a growing number of universities are offering interventions aimed at students, including MBI or mindfulness which is defined as the ability to pay attention to present moment experience with interest, curiosity, and acceptance MBI has been shown to have beneficial effects in students but the level of adherence to the program is low. One of the possible solutions could be the incorporation of virtual reality (VR) due to the high affinity of this population with new technologies and the increase in its frequency of use in neurorehabilitation and clinical psychology.
Objectives:
The study aims to examine the effects of a mindfulness-based intervention and a mindfulness-based intervention with virtual reality on occupational balance and on the reduction of psychological distress in university students (i.e. stress, anxiety and depression). The specific objectives will be to examine the effects of the intervention on other variables related to mental health, psychological functioning and occupations, and their maintenance at three months.
Methodology:
Single-blind, 3-arm randomized clinical trial (RCT): traditional MBI, MBI with VR, passive control group (waiting list), with 4 evaluation moments: pre-intervention, inter-session, post-intervention and follow-up. Participants will be undergraduate, master and doctoral students of the Miguel Hernández University of Elche, Alicante.
Intervention: Mindfulness-Based Intervention, Mindfulness-Based Intervention with virtual reality and Control group.
Variables and instruments:
This study will be carried out with mixed methodology. The quantitative part will be carried out by means of ad hoc questionnaires and measurement instruments adapted and validated in Spain, and by means of EMA (Ecological Momentary Assessment).
The qualitative part will be conducted through Focus Groups.
- Being tested
- Mindfulness program, Mindfulness program with Virtual Reality
- Keywords
- Mindfulness, Occupational Balance, Mental Health, University Students, Burnout Student
- Medical subject headings
- Burnout, Psychological, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness programBehavioural
Six weeks mindfulness program. The program is explained in arm descriptions.
Mindfulness program with Virtual RealityBehavioural
Six weeks mindfulness program. The program is explained in arm descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Health Care Program (MBHC). | Experimental | Mindfulness skills will take over a 6-week period. Mindfulness skills will deliver in a weekly group format. Participants will be instructed to follow mindfulness practice at home. The program is focused on cultivating mindfulness of present-moment, cultivating a nonreactive, nonjudgmental attitude toward the experience, and includes specific formal and informal practices aimed at cultivating healthy habits and lifestyle (e.g., activities of daily living such as feeding, bathing, or showering and other occupations such as communication management, health management, etc.; and prosocial components (e.g., kindness and compassion). Receives: Behavioral: Mindfulness program |
| Mindfulness-Based Health Care program with virtual reality (MBHC-VR). | Experimental | This program combines mindfulness practice with immersion in a virtual environment. The content and objectives of MBHC-VR program are the same that MBHC, with the main difference being that all formal practices of each session will be performed using VR. Receives: Behavioral: Mindfulness program with Virtual Reality |
| Waiting list control group (WL). | No intervention | Participants in the WL control group will not receive any intervention during the study. However, for ethical reasons, at the end of the 3-month follow-up assessment, participants of this WL control group will be invited to participate in the MBHC program free of charge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Occupational Balance
Occupational Balance Questionnaire (OBQ) is a brief 13-item tool scored on a 6-point Likert-type response scale, ranging from 0 (strongly disagree) to 5 (strongly agree), with a total score ranging from 0 to 65, where a higher score indicates greater occupational balance. A question from the Ecological Momentary Assessment questionnaire will also be used to evaluate this variable in the inter-session time frame.
Measured: Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Change in Anxiety, Depression and Stress
Anxiety, Depression and Stress Scale (DASS 21) consists of 21 items, 7 items for each subscale: DASS-D (depression), DASS-A (anxiety) and DASS-S (stress). Participants are asked to rate the degree to which this statement has happened to them in the past week on a scale from 0 (has not happened to me) to 3 (has happened to me a lot or most of the time). A question from the Ecological Momentary Assessment questionnaire will also be used to evaluate this variable in the inter-session time frame.
Measured: Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Change in Academic stress
SISCO Inventory which consists of 31 items distributed into: 1 filter item (yes-no), 1 item on a Likert-type scale from 1 (a little) to 5 (a lot), 8 items on a Likert-type scale from 1 (never) to 5 (always) that allow identifying stressful stimuli, 15 items on a Likert-type scale from 1 (never) to 5 (always) allowing to identify stressful stimuli divided into physical, psychological and behavioural reactions and 6 items on a Likert-type scale from 1 (never) to 5 (always) allowing to identify the frequency of use of coping strategies. A question from the Ecological Momentary Assessment questionnaire will also be used to evaluate this variable in the inter-session time frame.
Measured: Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Change in Burnout
Maslach Burnout Inventory-Student Survey Questionnaire (MBI-SS). The MBI-SS contains 15 items grouped into 3 subscales: Emotional Exhaustion (5 items), Cynicism (4 items), and Academic Efficacy (6 items). These items are scored on a scale from 0 (never/never) to 6 (always/every day). High scores on burnout and cynicism and low scores on academic efficacy are indicative of burnout. A question from the Ecological Momentary Assessment questionnaire will also be used to evaluate this variable in the inter-session time frame.
Measured: Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Secondary outcomes (9)
Change in Emotional dysregulation
Difficulties in Emotional Regulation Scale (DERS) contains 28 items grouped into 5 subscales: Attention-Inattention, Clarity-Confusion, Acceptance-Rejection, Functioning-Interference, and Regulation-Discontrol. These items are scored on a Likert-type scale from 1 (almost never) to 5 (almost always). Higher scores indicate greater difficulties in emotion regulation.
Measured: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Change in Psychological flexibility
Acceptance and Action Questionnaire II (AAQ-II) consists of 7 items to which participants respond on a 7-point Likert-type scale from 1 (never true) to 7 (always true). Scores range from 7 to 49. Higher scores indicate a tendency to act on the need to control or avoid aversive thoughts, memories, or feelings.
Measured: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Change in Mindfulness
Five Facets of Mindfulness Questionnaire Short-Form (FFMQ-SF) contains 24 items that assess the five facets of mindfulness: observing, describing, acting with awareness, non-judgement of inner experience, and non-reactivity to inner experience. It is scored on a Likert-type scale from 1 (never or very rarely true) to 5 (very often or always true). Higher scores indicate a greater capacity for mindfulness. A question from the Ecological Momentary Assessment questionnaire will also be used to evaluate this variable in the inter-session time frame.
Measured: Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Change in Self-compassion
Self-Compassion Scale short form (SCS-SF) consists of 12 items assessing 6 factors: Self-Kindness, Self-Judgment, Common Humanity, Isolation, Mindfulness, and Over-identification. Each item can be rated on a Likert-type scale from 1 (almost never) to 5 (almost always). Higher scores indicate greater self-compassion. A question from the Ecological Momentary Assessment questionnaire will also be used to evaluate this variable in the inter-session time frame.
Measured: Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Change in Life Satisfaction
Satisfaction with Life Scale (SLS) is composed of 5 items with a 7-point Likert-type scale (from 1, strongly disagree; to 7, strongly agree). The score ranges from 5 to 35, with higher scores indicating greater satisfaction.
Measured: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Change in Adherence to the Mediterranean Diet
Mediterranean Diet Adherence Test is a brief dietary assessment instrument consisting of a set of 14 short questions whose evaluation is intended to provide information on adherence to the Mediterranean Diet pattern. This questionnaire scores one point per question, with a score of <9 meaning low adherence and a score of >=9 meaning good adherence.
Measured: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Change in Sleep
Insomnia Severity Index (ISI) is a 5-item self-report instrument that assesses the severity of the sleep problem, the degree of dissatisfaction and the impact on quality of life. Scores range from 0 (best score) to 28 (worst score).
Measured: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Change in Physical Activity
International Physical Activity Questionnaire (IPAQ-SF) is a self-administered questionnaire consisting of 7 items that assesses the time spent being physically active in the last 7 days.
Measured: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Change in Mental representations
Plymouth Sensory Imagery Questionnaire (Psi-Q) consists of 21 items measuring 7 sensory modalities: vision, sound, smell, taste, touch, bodily sensation and emotions. The questionnaire has a Likert-type scale between 1 (no imagery) and 7 (perfectly clear and as vivid as the actual experience).
Measured: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start2 Nov 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Occupational BalanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled clinical trial (RCT) with three arms
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Complutense de Madrid
- Responsible party
- Principal investigator, ALICIA SANCHEZ PEREZ, Universidad Miguel Hernandez de Elche
- Investigators
- Alicia Sánchez Pérez, Ph.D, Principal investigator, Universidad Miguel Hernández- Facultad de Medicina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929430
- Sponsor's protocol ID
- Mind02UMH
- Acronym
- ATENEU
- Status last verified
- Dec 2024
- First submitted
- 26 May 2023
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Three members of the research group will be in charge of data collection under the supervision of the principal investigator of this research project. All digital data, including evaluation questionnaires and consent forms, will be stored as a data package on an encrypted hard drive, strictly following the data management guidelines of the Research Ethics And Integrity Committee from Miguel Hernández Univesity. Identifiable personal data will be stored separately from anonymous data to avoid identification of personal data during handling. The confidentiality of the participants will be protected following the ethical guidelines of the Research Ethics And Integrity Committee from Miguel Hernández Univesity. Once all phases of data collection have been completed, the data will be analyzed by 2 members of the group. Data will be available upon request to the corresponding author once the study is completed.
Publications
Sheldon E, Simmonds-Buckley M, Bone C, Mascarenhas T, Chan N, Wincott M, Gleeson H, Sow K, Hind D, Barkham M. Prevalence and risk factors for mental health problems in university undergraduate students: A systematic review with meta-analysis. J Affect Disord. 2021 May 15;287:282-292. doi: 10.1016/j.jad.2021.03.054. Epub 2021 Mar 26.
PubMed 33812241Yusoff MS, Abdul Rahim AF, Yaacob MJ. Prevalence and Sources of Stress among Universiti Sains Malaysia Medical Students. Malays J Med Sci. 2010 Jan;17(1):30-7.
PubMed 22135523Modrego-Alarcon M, Lopez-Del-Hoyo Y, Garcia-Campayo J, Perez-Aranda A, Navarro-Gil M, Beltran-Ruiz M, Morillo H, Delgado-Suarez I, Olivan-Arevalo R, Montero-Marin J. Efficacy of a mindfulness-based programme with and without virtual reality support to reduce stress in university students: A randomized controlled trial. Behav Res Ther. 2021 Jul;142:103866. doi: 10.1016/j.brat.2021.103866. Epub 2021 Apr 26.
PubMed 33957506Dhas BN, Wagman P. Occupational balance from a clinical perspective. Scand J Occup Ther. 2022 Jul;29(5):373-379. doi: 10.1080/11038128.2020.1865450. Epub 2020 Dec 31.
PubMed 33382004Regehr C, Glancy D, Pitts A. Interventions to reduce stress in university students: a review and meta-analysis. J Affect Disord. 2013 May 15;148(1):1-11. doi: 10.1016/j.jad.2012.11.026. Epub 2012 Dec 13.
PubMed 23246209Levit-Binnun N, Arbel K, Dorjee D. The Mindfulness Map: A Practical Classification Framework of Mindfulness Practices, Associated Intentions, and Experiential Understandings. Front Psychol. 2021 Oct 12;12:727857. doi: 10.3389/fpsyg.2021.727857. eCollection 2021.
PubMed 34712178Shapiro SL, Carlson LE, Astin JA, Freedman B. Mechanisms of mindfulness. J Clin Psychol. 2006 Mar;62(3):373-86. doi: 10.1002/jclp.20237.
PubMed 16385481Dawson AF, Brown WW, Anderson J, Datta B, Donald JN, Hong K, Allan S, Mole TB, Jones PB, Galante J. Mindfulness-Based Interventions for University Students: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. Appl Psychol Health Well Being. 2020 Jul;12(2):384-410. doi: 10.1111/aphw.12188. Epub 2019 Nov 19.
PubMed 31743957Sanchez-Perez A, Mendialdua-Canales D, Hurtado-Pomares M, Peral-Gomez P, Juarez-Leal I, Espinosa-Sempere C, Fernandez-Pires P, Zango-Martin I, Abellan-Miralles I, Lopez-Gonzalez P, Valera-Gran D, Navarrete-Munoz EM. The ATENcion Plena en Enfermedad de Alzheimer (ATENEA-Mindfulness in Alzheimer's Disease) Program for Caregivers: Study Protocol for a Randomized Controlled Trial. Healthcare (Basel). 2022 Mar 15;10(3):542. doi: 10.3390/healthcare10030542.
PubMed 35327020Lillo-Navarro C, Fernandez-Pires P, Benavides Gil G, Martinez-Zaragoza F, Chaves C, Roca P, Peral-Gomez P, Gonzalez Valero ME, Mendialdua Canales D, Poveda Alfaro JL, Goldin PR, Sanchez-Perez A. Effects of a mindfulness-based program on the occupational balance and mental health of university students. Protocol for a randomized controlled trial. PLoS One. 2024 May 2;19(5):e0302018. doi: 10.1371/journal.pone.0302018. eCollection 2024.
PubMed 38696406
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Mindfulness Program on the Occupational Balance and Mental Health of University Students. Protocol for a Randomized Controlled Trial Study. ATENEU Program (Mindfulness in University Students)
- ClinicalTrials.gov ID
- NCT05929430
- Acronym / sponsor ID
- ATENEU / Mind02UMH
- Keywords
- Mindfulness, Occupational Balance, Mental Health, University Students, Burnout Student
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Collaborators
- Universidad Complutense de Madrid
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to examine the effects of a mindfulness-based intervention and a mindfulness-based intervention with virtual reality on occupational balance and on the reduction of psychological distress in university students (i.e. stress, anxiety and depression). The specific objectives will be to examine the effects of the intervention on other variables related to mental health, psychological functioning and occupations, and their maintenance at three months.
Detailed description
The college student population is considered at high risk for developing mental health problems with the prevalence of depression being 34%, anxiety 32%, and sleep disorders 33% post-pandemic. This psychological distress affects students worldwide and is linked to poor academic performance and the presence of health risk behaviors such as substance use or suicide. Addressing student mental health is an urgent research priority. As such, a growing number of universities are offering interventions aimed at students, including MBI or mindfulness which is defined as the ability to pay attention to present moment experience with interest, curiosity, and acceptance MBI has been shown to have beneficial effects in students but the level of adherence to the program is low. One of the possible solutions could be the incorporation of virtual reality (VR) due to the high affinity of this population with new technologies and the increase in its frequency of use in neurorehabilitation and clinical psychology.
Objectives:
The study aims to examine the effects of a mindfulness-based intervention and a mindfulness-based intervention with virtual reality on occupational balance and on the reduction of psychological distress in university students (i.e. stress, anxiety and depression). The specific objectives will be to examine the effects of the intervention on other variables related to mental health, psychological functioning and occupations, and their maintenance at three months.
Methodology:
Single-blind, 3-arm randomized clinical trial (RCT): traditional MBI, MBI with VR, passive control group (waiting list), with 4 evaluation moments: pre-intervention, inter-session, post-intervention and follow-up. Participants will be undergraduate, master and doctoral students of the Miguel Hernández University of Elche, Alicante.
Intervention: Mindfulness-Based Intervention, Mindfulness-Based Intervention with virtual reality and Control group.
Variables and instruments:
This study will be carried out with mixed methodology. The quantitative part will be carried out by means of ad hoc questionnaires and measurement instruments adapted and validated in Spain, and by means of EMA (Ecological Momentary Assessment).
The qualitative part will be conducted through Focus Groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A randomized controlled clinical trial (RCT) with three arms
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Health Care Program (MBHC). | Experimental | Behavioral: Mindfulness programMindfulness skills will take over a 6-week period. Mindfulness skills will deliver in a weekly group format. Participants will be instructed to follow mindfulness practice at home. The program is focused on cultivating mindfulness of present-moment, cultivating a nonreactive, nonjudgmental attitude toward the experience, and includes specific formal and informal practices aimed at cultivating healthy habits and lifestyle (e.g., activities of daily living such as feeding, bathing, or showering and other occupations such as communication management, health management, etc.; and prosocial components (e.g., kindness and compassion). |
| Mindfulness-Based Health Care program with virtual reality (MBHC-VR). | Experimental | Behavioral: Mindfulness program with Virtual RealityThis program combines mindfulness practice with immersion in a virtual environment. The content and objectives of MBHC-VR program are the same that MBHC, with the main difference being that all formal practices of each session will be performed using VR. |
| Waiting list control group (WL). | No intervention | –Participants in the WL control group will not receive any intervention during the study. However, for ethical reasons, at the end of the 3-month follow-up assessment, participants of this WL control group will be invited to participate in the MBHC program free of charge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- being 18 years old or older
- being a degree, master or doctorate student at Miguel Hernández University
- speaking fluent Spanish
- signing the informed consent form
- having attended at least 4 of the 6 sessions (66% of the program)
Key exclusion criteria (6 listed)
- miss more than 2 out of 6 sessions (33% of the program)
- present a severe mental disorder in active phase diagnosed by a health professional (e.g., schizophrenia, bipolar disorder)
- are under the influence of alcohol or other drugs during sessions and/or assessments (determined by the program instructor)
- participate in another standardized meditation program during the study period
- withdrew before starting the intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness programSix weeks mindfulness program. The program is explained in arm descriptions. | Behavioural | Mindfulness-Based Health Care Program (MBHC). |
| Mindfulness program with Virtual RealitySix weeks mindfulness program. The program is explained in arm descriptions. | Behavioural | Mindfulness-Based Health Care program with virtual reality (MBHC-VR). |
Primary outcome
Change in Occupational Balance
Time frame: Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Occupational Balance Questionnaire (OBQ) is a brief 13-item tool scored on a 6-point Likert-type response scale, ranging from 0 (strongly disagree) to 5 (strongly agree), with a total score ranging from 0 to 65, where a higher score indicates greater occupational balance. A question from the Ecological Momentary Assessment questionnaire will also be used to evaluate this variable in the inter-session time frame.
Change in Anxiety, Depression and Stress
Time frame: Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Anxiety, Depression and Stress Scale (DASS 21) consists of 21 items, 7 items for each subscale: DASS-D (depression), DASS-A (anxiety) and DASS-S (stress). Participants are asked to rate the degree to which this statement has happened to them in the past week on a scale from 0 (has not happened to me) to 3 (has happened to me a lot or most of the time). A question from the Ecological Momentary Assessment questionnaire will also be used to evaluate this variable in the inter-session time frame.
Change in Academic stress
Time frame: Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).
SISCO Inventory which consists of 31 items distributed into: 1 filter item (yes-no), 1 item on a Likert-type scale from 1 (a little) to 5 (a lot), 8 items on a Likert-type scale from 1 (never) to 5 (always) that allow identifying stressful stimuli, 15 items on a Likert-type scale from 1 (never) to 5 (always) allowing to identify stressful stimuli divided into physical, psychological and behavioural reactions and 6 items on a Likert-type scale from 1 (never) to 5 (always) allowing to identify the frequency of use of coping strategies. A question from the Ecological Momentary Assessment questionnaire will also be used to evaluate this variable in the inter-session time frame.
Change in Burnout
Time frame: Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Maslach Burnout Inventory-Student Survey Questionnaire (MBI-SS). The MBI-SS contains 15 items grouped into 3 subscales: Emotional Exhaustion (5 items), Cynicism (4 items), and Academic Efficacy (6 items). These items are scored on a scale from 0 (never/never) to 6 (always/every day). High scores on burnout and cynicism and low scores on academic efficacy are indicative of burnout. A question from the Ecological Momentary Assessment questionnaire will also be used to evaluate this variable in the inter-session time frame.
9 secondary outcomes
Change in Emotional dysregulation
Time frame: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Change in Psychological flexibility
Time frame: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Change in Mindfulness
Time frame: Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Change in Self-compassion
Time frame: Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Change in Life Satisfaction
Time frame: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Change in Adherence to the Mediterranean Diet
Time frame: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Change in Sleep
Time frame: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Change in Physical Activity
Time frame: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Change in Mental representations
Time frame: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Background: PubMed 33812241Sheldon E, Simmonds-Buckley M, Bone C, Mascarenhas T, Chan N, Wincott M, Gleeson H, Sow K, Hind D, Barkham M. Prevalence and risk factors for mental health problems in university undergraduate students: A systematic review with meta-analysis. J Affect Disord. 2021 May 15;287:282-292. doi: 10.1016/j.jad.2021.03.054. Epub 2021 Mar 26.
- Background: PubMed 22135523Yusoff MS, Abdul Rahim AF, Yaacob MJ. Prevalence and Sources of Stress among Universiti Sains Malaysia Medical Students. Malays J Med Sci. 2010 Jan;17(1):30-7.
- Background: PubMed 33957506Modrego-Alarcon M, Lopez-Del-Hoyo Y, Garcia-Campayo J, Perez-Aranda A, Navarro-Gil M, Beltran-Ruiz M, Morillo H, Delgado-Suarez I, Olivan-Arevalo R, Montero-Marin J. Efficacy of a mindfulness-based programme with and without virtual reality support to reduce stress in university students: A randomized controlled trial. Behav Res Ther. 2021 Jul;142:103866. doi: 10.1016/j.brat.2021.103866. Epub 2021 Apr 26.
- Background: PubMed 33382004Dhas BN, Wagman P. Occupational balance from a clinical perspective. Scand J Occup Ther. 2022 Jul;29(5):373-379. doi: 10.1080/11038128.2020.1865450. Epub 2020 Dec 31.
- Background: PubMed 23246209Regehr C, Glancy D, Pitts A. Interventions to reduce stress in university students: a review and meta-analysis. J Affect Disord. 2013 May 15;148(1):1-11. doi: 10.1016/j.jad.2012.11.026. Epub 2012 Dec 13.
- Background: PubMed 34712178Levit-Binnun N, Arbel K, Dorjee D. The Mindfulness Map: A Practical Classification Framework of Mindfulness Practices, Associated Intentions, and Experiential Understandings. Front Psychol. 2021 Oct 12;12:727857. doi: 10.3389/fpsyg.2021.727857. eCollection 2021.
- Background: PubMed 16385481Shapiro SL, Carlson LE, Astin JA, Freedman B. Mechanisms of mindfulness. J Clin Psychol. 2006 Mar;62(3):373-86. doi: 10.1002/jclp.20237.
- Background: PubMed 31743957Dawson AF, Brown WW, Anderson J, Datta B, Donald JN, Hong K, Allan S, Mole TB, Jones PB, Galante J. Mindfulness-Based Interventions for University Students: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. Appl Psychol Health Well Being. 2020 Jul;12(2):384-410. doi: 10.1111/aphw.12188. Epub 2019 Nov 19.
- Background: PubMed 35327020Sanchez-Perez A, Mendialdua-Canales D, Hurtado-Pomares M, Peral-Gomez P, Juarez-Leal I, Espinosa-Sempere C, Fernandez-Pires P, Zango-Martin I, Abellan-Miralles I, Lopez-Gonzalez P, Valera-Gran D, Navarrete-Munoz EM. The ATENcion Plena en Enfermedad de Alzheimer (ATENEA-Mindfulness in Alzheimer's Disease) Program for Caregivers: Study Protocol for a Randomized Controlled Trial. Healthcare (Basel). 2022 Mar 15;10(3):542. doi: 10.3390/healthcare10030542.
- Derived from this study: PubMed 38696406Lillo-Navarro C, Fernandez-Pires P, Benavides Gil G, Martinez-Zaragoza F, Chaves C, Roca P, Peral-Gomez P, Gonzalez Valero ME, Mendialdua Canales D, Poveda Alfaro JL, Goldin PR, Sanchez-Perez A. Effects of a mindfulness-based program on the occupational balance and mental health of university students. Protocol for a randomized controlled trial. PLoS One. 2024 May 2;19(5):e0302018. doi: 10.1371/journal.pone.0302018. eCollection 2024.
- Individual participant dataSharing planned: No. Three members of the research group will be in charge of data collection under the supervision of the principal investigator of this research project. All digital data, including evaluation questionnaires and consent forms, will be stored as a data package on an encrypted hard drive, strictly following the data management guidelines of the Research Ethics And Integrity Committee from Miguel Hernández Univesity. Identifiable personal data will be stored separately from anonymous data to avoid identification of personal data during handling. The confidentiality of the participants will be protected following the ethical guidelines of the Research Ethics And Integrity Committee from Miguel Hernández Univesity. Once all phases of data collection have been completed, the data will be analyzed by 2 members of the group. Data will be available upon request to the corresponding author once the study is completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alicia Sánchez Pérez, Ph.D principal investigator
Universidad Miguel Hernández- Facultad de Medicina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness program and Mindfulness program with Virtual Reality in people with Occupational Balance and Mental Health Wellness, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alicia Sánchez Pérez, Ph.D (654486081, alicia.sanchez@umh.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Occupational Balance (time frame: Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05929430, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.